NCT02731963

Brief Summary

Colorectal surgery is highly associated with septic complications, therefore, multiple approaches have been used to reduce this complications, one of the most used is mechanical bowel preparation. Lately multiple studies have suggested that mechanical bowel preparation might not be necessary.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 8, 2016

Completed
Last Updated

April 8, 2016

Status Verified

April 1, 2016

Enrollment Period

5 months

First QC Date

April 4, 2016

Last Update Submit

April 7, 2016

Conditions

Anastomosis

Keywords

OutcomesBowel preparation

Outcome Measures

Primary Outcomes (3)

  • Number of Participants with Anastomotic leak

    Following the surgical procedure, anastomotic leak was evaluated with fecal discharge on drainage and confirmed with computerized tomography.

    6 weeks

  • Number of Participants with Surgical site infection

    Following the surgical procedure, surgical site infection was evaluated if the patient presented specific signs and symptoms for this condition (redness, delayed healing, fever, pain, tenderness, warmth, or swelling), and confirmation with culture of the purulent discharge.

    6 weeks

  • Number of Participants with Postoperative ileus

    Following the surgical procedure, ileus was evaluated if the patient presented distended and tympanic abdomen, and absence or hypoactive bowel sounds, and confirmed with a plain abdominal radiography.

    6 weeks

Secondary Outcomes (5)

  • Number of Participants with Fistula

    6 weeks

  • Number of Participants with Abdominal sepsis

    6 weeks

  • Number of Participants with Abscess

    6 weeks

  • Number of Participants with Pneumonia

    6 weeks

  • Number of Participants with Acute kidney injury

    6 weeks

Study Arms (2)

Mechanical bowel preparation

EXPERIMENTAL

80 Patients who received mechanical bowel preparation with 4 packets of polyethylene glycol in 4 liters of water, 4 hours before intervention.

Drug: Polyethylene glycol

No mechanical bowel preparation

NO INTERVENTION

81 Patients who received clear liquid diet 1 day before intervention.

Interventions

Polyethylene glycolDRUG

Patients with colorectal pathology who underwent elective colorectal anastomosis, that were randomized into two groups; one of them received mechanical bowel preparation with polyethylene glycol (study group), and the other one received clear liquid diet(control group) .

Mechanical bowel preparation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Entitlement to the Mexican Institute of Social Security
  • Signed informed consent
  • Patients with colorectal pathology who needed primary elective colorectal anastomosis
  • Body mass index \>18, and \< 31

You may not qualify if:

  • Patients who dropped out from the study or withdrew the informed consent
  • Patients who did not accepted the surgical procedure
  • Patients who had been submitted to surgery before entering the protocol
  • Patients who need a colostomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western Medical Center, Mexican Institute of Social Security

Guadalajara, Jalisco, 44340, Mexico

Location

MeSH Terms

Interventions

Polyethylene Glycols

Intervention Hierarchy (Ancestors)

Ethylene GlycolsGlycolsAlcoholsOrganic ChemicalsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Clotilde Fuentes, PhD

    Instituto Mexicano del Seguro Social

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

April 4, 2016

First Posted

April 8, 2016

Study Start

September 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2016

Last Updated

April 8, 2016

Record last verified: 2016-04

Locations

ME(1)